NAVKIDS² trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease - statistical analysis plan and update to the protocol.

ABSTRACT:

Background

This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS² trial of patient navigators for children with chronic kidney disease (CKD) experiencing social disadvantage and provides the statistical analysis plan (SAP) which has not previously been published.

Methods/design

The original protocol was published in BMC Nephrology ( https://doi.org/10.1186/s12882-019-1325-y ) prior to the commencement of trial recruitment. During the course of the trial, some key methodological changes needed to be made including changes to eligibility criteria (addition of patients with CKD stages 1-2, broadening of financial status eligibility criterion, addition of patients living in rural/remote areas, modificati

SUBMITTER: van Zwieten A 

PROVIDER: S-EPMC9522454 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature